Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of ozurdex steroid implants for dme after vitrectomy surgery

Conditions: Diabetic Macular Edema

Summary: currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. the use of the ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. the sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.

a total of 15 patients will be enrolled into the study. this is a 3 year randomized controlled study with the primary endpoint at 1 year. secondary safety and efficacy endpoints will be evaluated in year 2 and year 3. patients will be randomly enrolled into 1 of 3 groups: group 1: dexamethasone administered up to every 3 months group 2: dexamethasone administered up to every 6 months group 3: sham patients will be evaluated on a monthly basis with etdrs visual acuity, intraocular pressure, fundus examination and oct. ozurdex (dexamethasone) or sham procedure will be performed on day 0. all patients will be evaluated monthly thereafter. one month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. re-implantation of ozurdex may occur at any time \> 3 months following last injection in group 1 and \> 6 months following last injection in group 2 if any of the following conditions are met: 1. increase of \> 50 microns from the best previous crt measurement 2. recurrence of intraretinal cystic edema 3. persistent intraretinal cystic edema at 13 months, patients in the sham group will be eligible for ozurdex implantation if initial inclusion/exclusion criteria are met. these patients would follow re-implantation guidelines of group 2 (up to every 6 months).

Eligibility criteria:
inclusion criteria: 1. adults\> 18 years of age with type 1 or 2 diabetes mellitus 2. patients with dme secondary to diabetes mellitus involving the center of the macula oct thickness is \> 300 microns with intraretinal cystic edema 3. bcva between 20/40 to 20/400 4. patient had vitrectomy surgery. 5. provide a signed informed consent prior to any study procedure exclusion criteria: 1. patient unlikely to benefit from intravitreal ozurdex due to macular ischemia, atrophy, or other condition 2. patient with history of steroid response with iop \>35 mm hg or requirement to be on \> 2 glaucoma medications following previous steroid injection. 3. previous injection of anti-vegf or steroid in the study eye within 90 days 4. vitrectomy, cataract surgery, or yag capsulotomy within 90 days. 5. current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula. 6. pregnant, lactating females, or females of child-bearing potential that are not using reliable contraception.

Keywords: diabetic macular edema dme pars plana vitrectomy
decision aid for parents of infants with upjo

Conditions: Ureteropelvic Junction Obstruction; Ureteropelvic Junction; Obstruction, Congenital

Summary: ureteropelvic junction obstruction (upjo) is the most common etiology of high-grade hydronephrosis, affecting approximately 4,000-10,000 infants annually in the u.s. the goal of surgical treatment of upjo is to minimize the risk of kidney damage associated with obstruction, which may occur in 30-60% of infants with high-grade hydronephrosis.1-however, the benefit of early surgery compared to observation and potential later surgery to preserve kidney function has not been well-defined. consequently, surgeons differ on whether to initially treat with surgery or observation, with surgical rates in the first year of life varying from 15-50% across surgical practices. these variations are important to understand, as the decision for early surgery is not without risk. prior studies suggest that infants treated surgically are at higher risk for readmission and reoperation. early surgery also raises concerns about neurodevelopmental effects of anesthetic exposure. to address this gap, the purpose of this pilot test is to develop a patient decision aid (ptda) tool and pilot test its effect on parental understanding and engagement in the decision-making process at children's hospital colorado. the proposed pilot is a necessary first step in preparation for a future multicenter hybrid effectiveness-implementation trial. this work will also be used to support future studies evaluating the impact of a ptda on surgical variations and treatment outcomes in patients with upjo and other complex congenital urologic anomalies.


Eligibility criteria:
inclusion criteria (all of following are needed): * parents (age 18-89 years) of children age 30 days - 2 years * child is presenting for consultation for sfu grade 3-4 hydronephrosis at children's hospital colorado * parents/child presenting at urology appointment where a mag 3 is performed or has recently been performed. exclusion criteria: * does not meet age parameters * does not have a child with a upjo

Keywords: shared decision making pragmatic trial congenital kidney anomaly
advantages of autologous platelet-rich fibrin membrane on growth factor levels and periodontal healing

Conditions: Chronic Periodontitis

Summary: platelet rich fibrin is a second generation platelet concentration which contains various growth factors. the aim of this study is to evaluate the clinical and biochemical efficacy of prf in subjects of chronic periodontitis in the operation of conventional periodontal flap.

prf was developed in 2001 by choukroun in france, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing. many studies have shown beneficial effects of prf on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects. also prf contains many growth factors. prf accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration. in this study, the investigators evaluated the effect of prf on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.

Eligibility criteria:
inclusion criteria: * patients with cp who had pocket depth ≤ 5 mm and at least two area (grouped as control and prf) with horizontal bone loss after initial treatment exclusion criteria: * the subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months
prevalence of steatosis and steatohepatitis in patients undergoing bariatric surgery; a biopsy-based study

Conditions: Obesity; Obesity, Morbid; Bariatric Surgery Candidate; Steatosis of Liver; Steatohepatitis, Nonalcoholic

Summary: to study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.

a prospective single-center biopsy-based study was conducted on 162 sleeve gastrectomy patients. patient characteristics, including age, sex, diabetes mellitus (dm) status, body mass index (bmi), liver function tests, lipogram, homeostatic model assessment of insulin resistance (homa-ir), and steatosis were also assessed using controlled attenuation parameter (cap), and intra operative liver biopsies were obtained. , the presence of steatosis and steatohepatitis were histologically assessed by two expert pathologists.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic sleeve gastrectomy ≥18 years of age. * able to give written informed consent. * scheduled, independently from this study, to have a liver biopsy (lb). * negative for hepatitis b surface antigen, anti-hepatitis c virus, hepatitis c virus-rna, and hepatitis b virus dna. * bmi greater than or equal to 40, or bmi greater than or equal to 35 with at least one obesity-related comorbid condition (including type 2 diabetes, hypertension, hyperlipidemia, obstructive sleep apnea (osa), gerd, asthma, venous stasis disease, severe osteoarthritis, or considerably impaired quality of life). * unsuccessful nonoperative weight loss attempts. * mental health clearance. * recent updates have included patients with a bmi of 30-35 with uncontrollable type 2 diabetes or metabolic syndrome as an indication for a laparoscopic sleeve gastrectomy. exclusion criteria: * patients with ascites. * pregnant women. * patients with any active implantable medical device (such as pacemaker or defibrillator). * patients who had undergone liver transplantation. * patients with cardiac failure and significant valvular disease. * patients with hemochromatosis. * patients who refused to undergo liver biopsy or blood tests. * patients with alcohol consumption above recommended limits (\>14 units/week for women and \>21 units/week for men; 1 unit = 8 g of ethanol). * patients with a confirmed diagnosis of active malignancy or another terminal disease. * patients participating in another clinical trial within the preceding 30 days

Keywords: steatosis bariatric surgery liver biopsy
acurate ta™ valve implantation registry: savi 2

Conditions: Aortic Stenosis

Summary: post-market registry on acurate ta™ transapical aortic bioprosthesis and acurate ta™ delivery system implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.

the savi2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the symetis acurate ta™. the acurate ta™ is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (avr) via open surgery is considered to be associated with high surgical risk. the primary objectives of the registry is to further evaluate the safety and performance of the implantation and the safety at 30-day follow-up.

Eligibility criteria:
inclusion criteria: * patient has severe aortic stenosis * native aortic annulus diameter from ≥ 21mm up to ≤ 27mm * patient willing to participate in the study and provides signed ec-approved informed consent * the subject and treating physician agree the subject will return for all required post-procedure follow-up visits exclusion criteria: * patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the acurate ta™ and delivery system as per the instructions for use.

Keywords: tavi aortic stenosis transcatheter aortic valve replacement transcatheter aortic valve implantation transapical access
pilot study of rr-hnk in ocd

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to understand how rr-hnk works in the brain to bring about a reduction in ocd symptoms.

this protocol examines the safety and efficacy of 2 dosage levels of intravenous rr-hnk administration in individuals with ocd.

Eligibility criteria:
inclusion criteria: * ages 18-65 * meet the criteria for ocd diagnosis * failed at least 1 prior trial of standard first-line ocd treatment (e.g. sri/cbt) or or had refused these treatments for individual reasons * agree to the following lifestyle modifications: comply with requirements for fasting prior to --the infusion session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures. * able to provide informed consent exclusion criteria: * allergy or hypersensitivity to ketamine * any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician * pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control * lifetime history of deep brain stimulation

Keywords: ocd ampa receptor antagonist hydroxynorketamine ketamine metabolite
vaginal estradiol use in pessary care

Conditions: Pelvic Organ Prolapse; Urinary Incontinence; Pessary Ulcer of Vagina; Vaginal Atrophy

Summary: the primary outcome of this study compare the rate of pessary discontinuation at 6 months post-pessary fitting in women using vaginal estradiol versus those not using vaginal estradiol.

the purpose of the study is to investigate the effects of vaginal estradiol cream on pessary care. all patients presenting to the university of south florida urogynecology clinic for pessary fitting for pelvic organ prolapse and/or urinary incontinence are screened as potential study participants. after being informed of risks and benefits of participations and consent is obtained, patients that have been successfully fitted for a pessary and agree to participate will be separated into two groups: the control group or treatment group. the treatment group will be provided with a prescription for vaginal estradiol cream. vaginal estradiol cream is fda approved and is the first line treatment for vaginal atrophy, also known as dryness. the study will be unblinded and randomized, neither the participant nor the study doctor will choose which group the will be participant will be placed in. the participant will have an equal chance of being given either treatment. the treatment group will be asked to apply vaginal estradiol cream nightly for two weeks and then twice weekly thereafter. all participants will have 2 study visits over a 6-month period which is standard for pessary care: a regular follow up pessary check visit two weeks after pessary fitting and second visit 6 months later. at these visits, questions regarding symptoms including vaginal bleeding, vaginal discharge, and discomfort with pessary will be assessed and a physical exam will be performed as is standard for all pessary users.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * postmenopausal status * recent pessary fitting * office-based and home-based pessary care exclusion criteria: * women \< 18 years old * women currently on hormone replacement therapy (pill, patch, pellet) * women currently using vaginal estradiol cream within the last 4 weeks * medical contraindications to vaginal estradiol including unevaluated vaginal bleeding * inability to apply vaginal estradiol cream * inability to provide informed consent * inability to comprehend written and/or spoken english or spanish * inability to comply with study visit schedule

Keywords: pessary vaginal estradiol
arizona alzheimer's disease research center (adrc)

Conditions: Alzheimer Disease

Summary: the arizona alzheimer's disease research center (adrc) is the national institute on aging's (nia's) first statewide ad center (adc), the only adc in the southwestern united states, and a leading example of statewide collaboration in biomedical research. it capitalizes on arizona's strengths in brain imaging, genomics, computer science and biomathematics, the basic, cognitive and behavioral neurosciences, clinical, and neuropathological studies of ad, the discovery and evaluation of investigational treatments, and the study of normal cognitive aging.


Eligibility criteria:
inclusion criteria: * cognitively normal persons, individuals with mild cognitive impairment or dementia who are at least 40 years of age. * willing to undergo health and cognitive assessments, and collection and banking of blood with venipuncture for genetic research, biomarker research, and dna banking. exclusion criteria: * 1. participants whose diagnosis is unclear and confounded by multiple possible factors are excluded. participants with diagnoses of non-ad dementias are not excluded. 2. participants whose primary diagnosis is cognitive impairment due to a penetrating or single severe closed head injury, multiple sclerosis, brain tumor, metabolic or toxic encephalopathy, post-infectious (e.g., viral encephalitis, bacterial meningitis), paraneoplastic, primary psychiatric illness, or otherwise not deemed relevant to the intent of the alzheimer disease center program are excluded. 3. procedure specific exclusion criteria also apply but this does not impact the participants ability to be included in the study.
role of liver and visceral fat in glucose and lipid metabolism during pregnancy

Conditions: Pregnancy; Gestational Diabetes; Obesity; Liver Fat

Summary: obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be associated with adverse maternal and fetal pregnancy outcomes. this study will examine how fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to metabolize glucose (sugar) during pregnancy.

this study aims to serially evaluate liver and visceral fat stores during pregnancy and their relationship with glucose and lipid metabolism, placental function, and newborn size. to do this we will conduct both a prospective cohort study of pregnant women without pre-gestational or early gestational diabetes assessed at both 12-16 weeks gestation and at 32-36 weeks gestation and a case-control study of women with normal and impaired glucose tolerance in the early third trimester. physical assessments will be performed by the oregon health and science university bio-nutrition unit and will include the use of magnetic resonance imaging, ultrasound, and blood draws.

Eligibility criteria:
inclusion criteria: * pregnant and enrolled members of kaiser exclusion criteria: * women with multiples pregnancy; history of: cardiovascular disease, bariatric surgery, anemia, chronic hypertension or renal disease. * non-english speaker
a study of erdafitinib versus investigator choice of intravesical chemotherapy in participants who received bacillus calmette-guérin (bcg) and recurred with high risk non-muscle-invasive bladder cancer (nmibc)

Conditions: Urinary Bladder Neoplasms

Summary: the purpose of this study is to evaluate recurrence-free survival (rfs) in participants treated with erdafitinib vs investigator's choice, for participants with high-risk non-muscle-invasive bladder cancer (nmibc) who harbor fibroblast growth factor receptor (fgfr) mutations or fusions, and who recurred after bacillus calmette-guerin (bcg) therapy.

this study enrolls participants with high risk nmibc and fgfr mutations or fusions. erdafitinib is an oral pan-fibroblast growth factor receptor (fgfr) 1-4 inhibitor with demonstrated clinical activity in participants with solid tumors, including urothelial carcinoma, with alterations in the fgfr pathway. in cohort 1, participants will be randomized to erdafitinib or to investigators choice (intravesical gemcitabine or intravesical mitomycin c \[mmc\] or hyperthermic mmc). the study consists of screening period, treatment phase, follow-up phase, and long-term extension phase.

Eligibility criteria:
inclusion criteria: * histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. variant pathology are allowed * tumor with specified fibroblast growth factor receptor (fgfr) mutations or fusions * bacillus calmette- guerin (bcg)-unresponsive after adequate bcg therapy or bcg experienced participants * refuses or is not eligible for cystectomy (cohort 1 and cohort 2 only) * eastern cooperative oncology group (ecog) performance status grade 0-1 * must sign an informed consent form (icf) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * a woman of childbearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin \[beta-hcg\]) (urine or serum) within 7 days before randomization (cohort 1) or the first dose of study drug (cohort 2 and cohort 3) * adequate bone marrow, liver, and renal function as specified in the protocol exclusion criteria: * histologically confirmed, muscle-invasive (t2 or higher stage) urothelial carcinoma of the bladder * histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous cis of the bladder * prior treatment with an fgfr inhibitor * active malignancies other than the disease being treated under study. the only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (lcis) and ductal cis (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (n0m0) and receiving androgen deprivation therapy * current central serous retinopathy or retinal pigment epithelial detachment of any grade

Keywords: non muscle invasive bladder cancer (nmibc) bacillus calmette- guerin (bcg) failure bcg unresponsive
acute inflammation after wisdom tooth removal

Conditions: Tooth Impacted

Summary: third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry. nevertheless, little is known about the level of general body inflammation of subjects with impacted or semi-impacted third molars. moreover, the possible effects of surgical removal of wisdom teeth on the overall health are not known. thus, a study in which 40 subjects has been designed. twenty subjects were affected by bilateral wisdom tooth pathology necessitating for extraction of both teeth. control group comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without pathology associated to or history of previous extraction of both wisdom teeth. in both groups a medical and dental examination will be performed at the baseline and 3 months after baseline for the control group or after the second third molar extraction in the control group. blood will be also withdrawn to assess systemic inflammation and other systemic parameters. parameter were evaluated via high sensitive c reactive protein (crp), lipids, fibrinogen, oxidative stress and endothelial function analysis.

third molar extraction is one of the most frequent intervention in dentistry. nevertheless, little is known about the systemic aspect of subjects with impacted or semi-impacted third molars and the possible effects of surgical removal on their systemic parameters. a case-control study of 40 subjects has been designed to evaluate i) the overall systemic inflammation and metabolism of subjects with bilateral third molars compared to subjects with no third molars and ii) the effect of bilateral removal in the immediate and medium postsurgical period. systemic parameters are evaluated via high sensitive c reactive protein (crp), lipids, fibrinogen, oxidative stress and endothelial function analysis.

Eligibility criteria:
inclusion criteria: * cases: bilateral wisdom tooth pathology. * control: agenesia/previous extraction/no symptoms of the lower third molars. exclusion criteria: * younger than 18 years and older than 65 years; * pregnant or lactating females; * females using contraceptive methods; * suffering from any systemic illness; * undergoing any pharmacological treatment within 30 days prior to the inclusion * patients affected by periodontal disease (radiographic diagnosis of vertical bone defects or bone resorption equal to 20% of the root length); * patients with periapical and periradicular radiolucent areas x-ray detectable; * patients unable to participate to study.

Keywords: c-reactive protein systemic inflammation third molar wisdom tooth